Characterizing the Clinical Risk State for Bipolar Disorder in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- Number of subjects with development of a bipolar or schizophrenia disorder
研究概览
简要总结
Aim: The purpose of the study is to characterize the at-risk phases preceding a first episode of bipolar disorder and of schizophrenia, and to identify clinical and biological predictors of the disease development.
Hypothesis a: Over 6-24 months, 25% of at-risk youth will develop the full manifestations of Bipolar Disorder (BPD) or schizophrenia.
Hypothesis b: The symptoms utilized for characterizing the at-risk phase of BPD will differentiate between individuals developing BPD and schizophrenia.
详细描述
Prospective, naturalistic, cohort study aiming to characterizing the bipolar and psychotic prodrome thoroughly with a variety of clinical and biological measures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 12-18 years;
- •Sex: male or female;
- •Race/ethnicity: no restrictions;
- •Definite or suspected chart diagnosis of BP-II, BP-NOS, cyclothymia, MDD, depressive disorder NOS, dysthymia or mood disorder NOS, schizophrenifiorm disorder or psychotic disorder NOS;
- •Subject and parent (if subject<18) willing and able to provide written, informed consent/assent.
排除标准
- •Estimated Premorbid IQ < 70;
- •Meets DSM-IV criteria for BP-I or schizophrenia, pervasive developmental disorder, autism spectrum disorders, current substance dependence;
- •History of medical condition known to affect the brain;
- •current group home affiliation.
结局指标
主要结局
Number of subjects with development of a bipolar or schizophrenia disorder
时间窗: within 60 months
Diagnostic conversion
次要结局
- Psychopathology(within 60 months)
研究者
Christoph U. Correll, MD
Principal Investigator
Northwell Health